ACRP CP Exam UPDATED Questions and
CORRECT Answers
1571 - CORRECT ANSWERS IND application; Permit to do research on humans for the
first time; has background info; and rationale; updated annually
1572 - CORRECT ANSWERS Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - CORRECT ANSWERS Clinical and non-clinical data on the investigational product
that is relevant to the study in human subjects; supplied prior to regulatory approval
Study type - Open Label - CORRECT ANSWERS everyone knows the treatment
Study type - Single blind - CORRECT ANSWERS one party knows Tx, usually the patient
does not know but the monitoring team does
Study type - Double Blind - CORRECT ANSWERS 2 or more people are blinded, usually
the patient and monitoring tram do not know which drug is given.
A 3rd party unblinded pharmacist is used and an unblinded CRA is needed
Study Type - Double dummy - CORRECT ANSWERS Use to blind similar Tx's; one is
active and one is placebo. This occurs when the drug and placebo cannot be made identical (pill
vs liquid)
Study Type - Parallel - CORRECT ANSWERS Two groups of treatments. One group
receives only treatment A and another group receives only treatment B
, Study Type - Crossover - CORRECT ANSWERS Usually Chronic disease; receives more
than one Tx with a washout in between. A then B; could be randomized so the sequence changes
Define Overall Survival - CORRECT ANSWERS the length of time from treatment until
time of death. In a clinical trial, measuring the overall survival is one way to see how well a new
treatment works.
Define Cohort - CORRECT ANSWERS Subjects are matched for similar groups; ex:
Smokers, sex and age
Study Type - Placebo control - CORRECT ANSWERS in addition to a group of subjects
that receives the treatment to be evaluated, a separate control group receives a placebo
Study Type - Active control - CORRECT ANSWERS Done when use of placebo is
unethical like antibiotics studies.
Means that a known, effective treatment (as opposed to a placebo) is compared to an
experimental treatment
Define Randomization - CORRECT ANSWERS method used to equify distribution of Tx
to subjects; to eliminate bias
Define Stratification - CORRECT ANSWERS method used to control assignment based
on variables; like disease status; ALLOWS BALANCED COMPARABILITY
What are PK studies? - CORRECT ANSWERS Involves taking several blood samples
over a period of time to determine how the body handles the substance
What is an IDE? - CORRECT ANSWERS Investigational device exemption
CORRECT Answers
1571 - CORRECT ANSWERS IND application; Permit to do research on humans for the
first time; has background info; and rationale; updated annually
1572 - CORRECT ANSWERS Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - CORRECT ANSWERS Clinical and non-clinical data on the investigational product
that is relevant to the study in human subjects; supplied prior to regulatory approval
Study type - Open Label - CORRECT ANSWERS everyone knows the treatment
Study type - Single blind - CORRECT ANSWERS one party knows Tx, usually the patient
does not know but the monitoring team does
Study type - Double Blind - CORRECT ANSWERS 2 or more people are blinded, usually
the patient and monitoring tram do not know which drug is given.
A 3rd party unblinded pharmacist is used and an unblinded CRA is needed
Study Type - Double dummy - CORRECT ANSWERS Use to blind similar Tx's; one is
active and one is placebo. This occurs when the drug and placebo cannot be made identical (pill
vs liquid)
Study Type - Parallel - CORRECT ANSWERS Two groups of treatments. One group
receives only treatment A and another group receives only treatment B
, Study Type - Crossover - CORRECT ANSWERS Usually Chronic disease; receives more
than one Tx with a washout in between. A then B; could be randomized so the sequence changes
Define Overall Survival - CORRECT ANSWERS the length of time from treatment until
time of death. In a clinical trial, measuring the overall survival is one way to see how well a new
treatment works.
Define Cohort - CORRECT ANSWERS Subjects are matched for similar groups; ex:
Smokers, sex and age
Study Type - Placebo control - CORRECT ANSWERS in addition to a group of subjects
that receives the treatment to be evaluated, a separate control group receives a placebo
Study Type - Active control - CORRECT ANSWERS Done when use of placebo is
unethical like antibiotics studies.
Means that a known, effective treatment (as opposed to a placebo) is compared to an
experimental treatment
Define Randomization - CORRECT ANSWERS method used to equify distribution of Tx
to subjects; to eliminate bias
Define Stratification - CORRECT ANSWERS method used to control assignment based
on variables; like disease status; ALLOWS BALANCED COMPARABILITY
What are PK studies? - CORRECT ANSWERS Involves taking several blood samples
over a period of time to determine how the body handles the substance
What is an IDE? - CORRECT ANSWERS Investigational device exemption
